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Hep C Update

If you have lived a relatively clean life, you might think the odds of your suffering from hepatitis C might be as small as the odds of winning a lottery, but a study released last week indicates that just being a baby boomer is a risk factor.

This is a lottery you wouldn’t want to win. Getting tested for the virus, as recommended by Dr. Julio Montaner, director of the B.C. Centre of Excellence in HIV/AIDS, is a small price to pay for health and peace of mind.

Hepatitis C has long been associated with risky lifestyles — particularly indiscriminate sexual activity, dodgy tattoo procedures or the injection of recreational drugs — with symptoms of the disease sometimes showing up decades after the initial infection. Those are still high-risk factors, but a study released last week dispels the notion that the virus hits only those who were careless during the Summer of Love or who now live risky lifestyles.

The study, undertaken by the Centre of Excellence with the U.S. Centers for Disease Control, discovered the hepatitis C epidemic in North America peaked between 1940 and 1965, with most of those infected coming into contact with the disease in hospitals and by improperly sterilized medical syringes.

Advancements in medical procedures, as well as improved screening of blood products, have helped stem the spread of the virus, but anyone born between 1945 and 1964 is considered to be at risk of carrying the disease.

“Based on our results, the oldest members of the demographic cohort with the highest burden of hepatitis C virus (the baby boomers) were roughly five years of age around the peak of the spreads of genotype 1a in North America in 1950,” wrote the authors of the study. “Thus, it is unlikely that past sporadic risky behaviour … was the dominant route of transmission in this group.”

A 2014 Canada Communicable Disease Report estimated 240,000 Canadians were living with chronic hepatitis C in 2011. Cynthia Carter, a Saanich volunteer with the B.C. Hepatitis C Education and Prevention Society, says B.C. residents account for a disproportionately large chunk at about 80,000.

The sex-and-drug link has led to a stigma against testing among groups thought to be at low risk of infection. The result of that attitude, says the Public Health Agency of Canada, is that 44 per cent of Canadians with hepatitis C are not aware that they are infected and spreading the disease.

“Any baby boomer could be living with HCV [hepatitis C virus], even in the absence of symptoms or any history of high-risk behaviours, and as such they should be encouraged to proactively seek HCV testing,” Montaner says.

Typically, hepatitis C shows no symptoms at the time of infection and takes decades to do its damage. But 75 to 85 per cent of people with HCV develop chronic hepatitis, according to the U.S. Centers for Disease Control and Prevention. Some of those infected outlive the virus and live healthy lives, but up to 20 per cent develop cirrhosis, an incurable disease, and one to five per cent will die of liver disease or liver cancer.

“Hepatitis C is a time bomb, and it’s obviously not being addressed appropriately,” Montaner says.

Provinces and territories should provide screening to detect the disease, which is curable in up to 95 per cent of cases, he says.

Hepatitis C is referred to as a hidden epidemic, because so many carriers aren’t aware they have the disease. But this is an epidemic we can avert — through proper screening and treatment, where necessary.

The FDA approved Harvoni (ledipasvir/sofosbuvir) for two new indications that will expand its use in liver transplant patients with HCV as well as those with decompensated cirrhosis, who generally have a poor prognosis and often go on to require a liver transplant.

Previously treatment options in these patients have been limited and often involved injectable and hard-to-tolerate interferon alpha therapy. Now they will be able to receive a 12-week, oral course of Harvoni, expanding the target patient population for a drug that brought in nearly $14bn in sales last year.

Specifically, the US regulator has approved Harvoni in combination with ribavirin chronic HCV genotype (GT) 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis, as well as for GT 1-infected patients with decompensated cirrhosis, including those who have received a liver transplant.

Gilead has been expanding the use of Harvoni as the drug starts to face competition from rival oral HCV therapies, including AbbVie’sViekirax/Viekira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) and Merck & Co’s recently-approved Zepatier (elbasvir/grazoprevir), which has undercut Harvoni on price.

Last November, the FDA approved Harvoni for expanded use in patients with genotype 4, 5, and 6 chronic HCV infections and in patients co-infected with HIV. It also cleared a 12-week Harvoni and ribavirin regimen as an alternate therapy to 24 weeks of Harvoni for treatment-experienced genotype 1 patients with cirrhosis.

All told, Harvoni and Sovaldi (sofosbuvir) have been used to treat more than 750,000 patients with HCV around the world and the success of the new oral HCV therapies have raised the real prospect of eradicating HCV.

Despite the number of patients treated to date, there are still millions of HCV-infected individuals who have yet to be treated and many that have yet to be diagnosed, according to Gilead, which believes HCV will remain a sustainable market for the foreseeable future.

The company is also hoping to launch a follow-up to Harvoni, which covers a broader range of HCV genotypes and should extend the franchise.

The eye-opening film uncovers the country’s hidden hepatitis C epidemic. Today, 300,000 to 500,000 Canadians are estimated to have hepatitis C, a deadly virus that attacks the liver and can lead to liver cancer, transplantation, or death. Currently, hepatitis C causes more deaths and years of life lost than any other infectious disease in Canada, including HIV/AIDS. While the disease can affect anyone, Baby Boomers currently make up approximately 70% to 80% of hepatitis C cases in Canada, but many of them are unaware they have the virus.

“The difficulty with hepatitis C is that there are no symptoms that appear until it’s too late,” says Dr. Hemant Shah, Clinical Director, Francis Family Liver Clinic, University Health Network in Toronto, who was interviewed for the film. “It’s like you’re walking towards a cliff. You’re looking towards the horizon, but you don’t appreciate that the ground is about to give way and you feel perfectly fine as you walk towards that cliff.”

Thanks to the emergence of new drug therapies, hepatitis C (HCV) is now one of the few chronic diseases that, in most cases, can be cured – provided it’s caught and treated soon enough.

To get the word out to at-risk Canadians [http://bit.ly/1Iee3EM] on the importance of getting tested and treated for HCV, the documentary’s producers have launched the “Deal with it / Dealt with it” awareness campaign in the lead up to World Hepatitis Day on July 28. The producers are asking anyone who has been touched by the disease to post a video or photo on Facebook and/or Twitter (#DealwithitHCV) wearing a “Deal with it / Dealt with it” wristband explaining how they are personally dealing with, or have dealt with, hepatitis C.

There is a huge public stigma surrounding hepatitis C that continues to prevent people from getting tested and treated for the disease, says Shah.

“The film does an excellent job of documenting the harm this prejudice causes individuals who have been diagnosed with HCV,” he added. “My hope is that THE CAMPAIGN will broaden the public’s understanding of this disease. I strongly encourage everyone who is battling, or who has beaten, hepatitis C to talk about it on social media and elsewhere on world hep day (July 28th) and beyond.”

Scotch Plains, NJ & San Francisco, CA — May 19, 2015 – Help-4-Hep, a non-profit, peer-to-peer helpline where counselors work with patients to meet the challenges of hepatitis C, is launching today a new web and mobile app to bring its highly effective peer counselling services as well as a new self-care tool to more people affected by hepatitis C.

Hepatitis C is a silent and potentially deadly liver disease and a serious health issue affecting our population. For up to 80% of people who contract hepatitis C, the illness moves into a long-term phase called chronic hepatitis C. Up to 5 million people in the United States today are living with chronic hepatitis C, and more people in the US die from the disease than from HIV. In recognition of the importance of creating awareness and educating the general public about this illness, this May is Hepatitis Awareness Month and today is Hepatitis Testing Day.

Help-4-Hep’s web and mobile app was developed in partnership with patient intelligence health solution provider, Self Care Catalysts (SCC). The Help-4-Hep app is part of Self Care Catalyst’s popular Health Storylines platform, leveraged by a wide number of patient communities to improve self-care and management of chronic conditions.

The app provides a suite of self-care tools for people living with chronic hepatitis C to help them better manage their illness and prepare for their treatment journey. It offers tools such as the ability to log lab tests, includes a food diary to help manage diet and nutrition and a mood tracker, allowing people living with hep C to chronicle their emotions and feelings. Individuals can also call the Help-4-Hep hotline directly from the app and discuss their condition with their counsellor.

Help 4 Hep aims to support more individuals living with hep C who are waiting for treatment. Physicians and nurses can also benefit from recommending the app to support their patients between visits.

“It’s incredibly important for people with chronic hepatitis C to take control of their health by tracking day to day routines and behaviors such as the amount of sleep and exercise they are getting and by eating well. We are truly excited to be able to extend our network of support into the web and mobile world, so we can reach and help more people affected by hepatitis C,” says Dennis Simon, Managing Partner, Help-4-Hep.

Help-4-Hep’s web and mobile app is officially launching today on Hepatitis Testing Day. It is free and available on desktop, laptop, mobile and tablet devices. Interested users can sign-up on the Web, or download the app from the App Store? or from Google Play™. The app is available both in Canada and the US.

About Help-4-Hep

Help?4?Hep is a non-profit, peer-to-peer helpline where counselors work with patients to meet the challenges of hepatitis C head-on. Callers talk one-to-one with a real person, typically someone who’s had hepatitis C touch their own life. And they talk about the specifics of their particular situation. The phone call, support and information are all provided free of charge. Help-4-Hep is also the creator of the The Support Partnership – a network of nationally recognized nonprofits that have nearly 100 years of combined experience with peer helplines, hepatitis C support, education, testing, treatment and advocacy. For more information visithttp://www.help4hep.org/. For counselling support call the Help-4-Hep hotline toll free at 877-Help-4-Hep.

About Self Care Catalysts
Self Care Catalysts is a patient solutions, intelligence and analytics company that enables healthcare innovation. We are committed to advocating for patients and consumers when it comes to healthcare decisions. Our belief is that when patients are informed, respected, and engaged, they make better choices. Better choices mean better health outcomes.

Our mission is to build innovative, patient-centered, and technology-driven self-care solutions that will enable patients to continue managing their care outside of the clinical setting. www.selfcarecatalysts.com

Tuesday, May 5, 2015 (HealthDay News) — Researchers have released yet another study finding impressive results for an experimental drug combo that aims to rid the body of infection with liver-damaging hepatitis C.

In this case, a combination of three drugs in the pipeline — daclatasvir, asunaprevir and beclabuvir — effectively cleared the virus in 93 percent of patients, according to new research from Duke University in Durham, N.C. All of the patients had already developed an infection-linked scarring of the liver known as cirrhosis.

None of these drugs has been approved by the U.S. Food and Drug Administration, but daclatasvir is currently under FDA review, according to a Duke news release.

One U.S. expert said the drug combination could be an additional advance against hepatitis C.

“This regimen is yet another all-oral treatment for the most common type of hepatitis C, which offers high cure rates with what appears to be an excellent tolerability profile,” said Dr. David Bernstein, chief of the division of hepatology at North Shore University Hospital in Manhasset, N.Y.

The study is published in the May 5 issue of the Journal of the American Medical Association.

As the researchers noted, for the past two decades treatment for hepatitis C has largely relied on interferon drugs, involving regular injections. The treatment, which can last for up to a year, is associated with severe flu-like symptoms, and many people discontinue the medication due to these unwanted side effects. Other patients are not able to take interferon because they are anemic, have a low platelet count or have another health issue.

The new study’s lead author explained: “Those with more advanced disease were unlikely to tolerate interferons, and many patients would decide against even getting treatment,” said Dr. Andrew Muir, chief of the division of gastroenterology at Duke. “For those who could tolerate it, it was only moderately effective,” he said in the news release.

However, since 2013, several drug companies have released new hepatitis C treatments that do not involve interferon drugs such as Sovaldi (sofosbuvir) or Harvoni (lepdipasvir-sofosbuvir). While very expensive, these drugs have also been very effective in safely ridding the body of hepatitis C.

“The development of interferon-free treatments has been a tremendous step forward in the standard of care,” Muir said. “These drugs are highly effective and well-tolerated by patients at all stages of liver disease.”

The new study was funded by drug maker Bristol-Myers Squibb. It involved 112 patients with cirrhosis related to hepatitis C that were never treated, as well as 90 who had undergone unsuccessful treatment for the condition.

The patients were treated between December 2013 and September 2014 at nearly 50 locations across the United States, Canada, France and Australia. All of the participants had genotype 1 hepatitis — a common strain of the hepatitis C virus in North America, Western Europe and Australia.

The three-drug regimen cleared the virus in 93 percent of patients with cirrhosis, according to a new study. The patients who benefited from the 12-week dose of three different drugs hadn’t received any previous treatment, the study’s authors noted.

The researchers found the drugs were less effective for those who’d been treated unsuccessfully in the past. The combination treatment eliminated the virus in 87 percent of these patients, suggesting their disease could be resistant to treatment.

Therapy was slightly more effective however, when these patients were given a fourth drug, ribavirin, which is commonly used to treat hepatitis C. After taking the additional drug, success rates jumped to 93 percent, according to the study.

Most of the patients had minor side effects. Nine of them developed serious health issues, but just three were considered related to the treatment.